Media Releases

11 August 2012

Health Canada approved the first DNA CMV test to be standardized to the WHO International Standard for CMV quantitation. This first CMV test provides clinical value to help clinicians manage solid organ transplant patients on antiviral therapy

Health Canada approved the first DNA CMV test to be standardized to the WHO International Standard for CMV quantitation. This first CMV test provides clinical value to help clinicians manage solid organ transplant patients on antiviral therapy.

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received approval from Health Canada for a new test to assess a patient’s viral load of cytomegalovirus (CMV). The fully automated COBAS® AmpliPrep / COBAS® TaqMan®CMV Test is the first Health Canada approved test to be standardized to the WHO International Standardfor use in quantifying CMV DNA in human plasma specimens. Clinicians use CMV DNA viral load information from the test to help manage patients who have been diagnosed with CMV disease, specifically patients whose immune system has been suppressed for solid organ transplantation.

“The first CMV test is a great clinical innovation that will definitely improve patient care for solid organ transplant recipients’’, said Ian Parfrement, President & General Manager of Roche Diagnostics Canada. “We are proud to offer a Health Canada approved test that is standardized and automated CMV viral load testing that improves laboratory’s workflow’’.

About the testThe COBAS® AmpliPrep / COBAS® TaqMan®CMV Test is intended to be used in conjunction with clinical presentation and other laboratory markers in the management of CMV infection in patients at risk for CMV disease. In this population, the test can be used to assess response to antiviral treatment. The test is traceable to the first WHO International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC 09/162) and reliably monitors cytomegalovirus (CMV) infections.

About the COBAS® AmpliPrep / COBAS® TaqMan® System Roche’s fully automated COBAS AmpliPrep/COBAS TaqMan® System combines the COBAS AmpliPrep Instrument for automated sample preparation and the COBAS TaqMan® Analyzer or the smaller COBASTaqMan® 48 Analyzer for automated real-time PCR amplification and detection. The COBAS AmpliPrep/COBAS TaqMan® System has parallel processing with other key molecular diagnostics assays targeting medically relevant diseases (Hepatitis B virus, Hepatitis C virus, and Human Immunodeficiency Virus). Roche’s AmpErase® enzyme is also included in each test and is designed to prevent carryover contamination by destroying any amplicon previously generated.

About Cytomegalovirus CMV is the most common and important viral infection in solid organ transplant (SOT) recipients. The virus can be transmitted through the donor organ, resulting in CMV infection and leading to the development of CMV disease, or can occur by reactivation of the virus in transplant recipients with previous CMV infection. CMV disease in transplant recipients may be similar to infectious mononucleosis with fever or can be more serious with involvement of the lung or gastrointestinal tract. Between 50 – 80% of all people in Canada become infected with CMV. Although healthy persons usually have few symptoms at the time of initial infection, after infection the virus remains in a latent state in the body for the rest of a person's life. The virus can then be transmitted and cause infection through organ donation, or latent virus in the transplant recipient can become reactivated and cause symptomatic disease.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80’000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. Roche Canada was founded in 1931. The company employs approximately 900 people across the country, with its pharmaceuticals head office located in Mississauga, Ontario and diagnostics division based in Laval, Quebec. Roche Canada is actively involved in local communities, investing in charitable organizations and partnering with healthcare institutions across the country. For more information, visit www.rochecanada.com.

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